EP0920849A2 - Sac pour solutions d'infusion et procédé de fabrication - Google Patents
Sac pour solutions d'infusion et procédé de fabrication Download PDFInfo
- Publication number
- EP0920849A2 EP0920849A2 EP19980304166 EP98304166A EP0920849A2 EP 0920849 A2 EP0920849 A2 EP 0920849A2 EP 19980304166 EP19980304166 EP 19980304166 EP 98304166 A EP98304166 A EP 98304166A EP 0920849 A2 EP0920849 A2 EP 0920849A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- infusion solution
- bag
- weak seal
- seal portion
- chambers
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/76—Making non-permanent or releasable joints
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/05—Particular design of joint configurations
- B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
- B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
- B29C66/112—Single lapped joints
- B29C66/1122—Single lap to lap joints, i.e. overlap joints
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/345—Progressively making the joint, e.g. starting from the middle
- B29C66/3452—Making complete joints by combining partial joints
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
- B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
- B29C66/43—Joining a relatively small portion of the surface of said articles
- B29C66/431—Joining the articles to themselves
- B29C66/4312—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
- B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
- B29C66/53261—Enclosing tubular articles between substantially flat elements
- B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
- B29C66/53263—Enclosing spouts between the walls of bags, e.g. of medical bags said spouts comprising wings, e.g. said spouts being of ship-like or canoe-like form to avoid leaks in the corners
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
- B65D81/3261—Flexible containers having several compartments
- B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2024—Separating means having peelable seals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/82—Testing the joint
- B29C65/8207—Testing the joint by mechanical methods
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
- B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
- B29C66/43—Joining a relatively small portion of the surface of said articles
- B29C66/431—Joining the articles to themselves
- B29C66/4312—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
- B29C66/43129—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams said flat seams being transversal but non-orthogonal with respect to the tubular or hollow articles, i.e. oblique
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
- B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
- B29C66/91411—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
- B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
- B29C66/929—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools characterized by specific pressure, force, mechanical power or displacement values or ranges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/04—Polymers of ethylene
- B29K2023/08—Copolymers of ethylene
- B29K2023/083—EVA, i.e. ethylene vinyl acetate copolymer
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/10—Polymers of propylene
- B29K2023/12—PP, i.e. polypropylene
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7148—Blood bags, medical bags
Definitions
- the present invention relates to a bag for an infusion solution particularly having a structure capable of easily mixing, at a time of use, an infusion solution with another infusion solution or a medicament other than the infusion solution which have been preliminarily independently sealed in the bag and also relates to a method of manufacturing such infusion solution bag.
- an infusion solution bag having an inner space which is divided into a plurality of small chambers or sections into which infusion solutions, or infusion solution and a medicament other than the infusion solution, are accommodated respectively.
- These small chambers are sectioned by boundary portions which are sealed to be openable.
- These infusion solutions or medicament solutions stored in the respective chambers can be mixed together by opening the boundary portions just before the use.
- a shell portion of the infusion solution bag is pinched from the outer side thereof at several portions by using pinching members to divide the inner space of the bag into a plurality of small chambers or sections and various infusion solutions or the like are accommodated into these divided sections respectively.
- the pinching members are removed at the time of prescription to mix these infusion solutions together.
- opposing film materials constituting both surfaces of an infusion solution bag are closed, through a heat sealing process, at boundary portions by which the inner space of the infusion solution bag is divided into a plurality of small sections.
- a port forming member is mounted to a part of each boundary portion, infusion solutions or other medicament solutions are accommodated in the small sections respectively, and these solutions are mixed at the infusion solution prescription time by breaking, for example, bending, the port forming member.
- prior art provides a method in which opposing film materials, constituting both surfaces of an infusion solution bag, are closed, through a heat sealing process, with a resin film being interposed therebetween for weakening a sealing strength, at boundary portions by which the inner space of the infusion solution bag is divided into a plurality of small sections.
- Infusion solutions or other medicament solutions are accommodated into these small sections or chambers, and when it is required to mix these solutions in the respective small sections together, the weakly sealed part of the boundary portion is separated by applying pressure to the bag body and, then, the solutions in the respective sections are mixed through the opened boundary portion.
- An object of the present invention is to substantially eliminate defects or drawbacks encountered in the prior art described above and to provide a bag for an infusion solution which has an inner space divided into a plurality of chambers or sections into which infusion solutions, or infusion solution and a medicament other than the infusion solution, are accommodated respectively, and these chambers are sectioned by weakly sealed portions which are openable, these chambers having optional shapes as occasion demands.
- Another object of the present invention is to provide a method of effectively manufacturing an infusion solution bag, which has an inner space divided into a plurality of chambers or sections into which infusion solutions, or infusion solution and a medicament other than the infusion solution, are accommodated respectively, and these chambers are sectioned by weakly sealed portions which are openable, in a material saving manner with reduced working labor.
- a bag for an infusion solution having front and back wall portions each formed of a flexible plastic film and provided with a plurality of chambers which are filled with one infusion solution and another infusion solution or medicament, independently, the chambers being sectioned by a boundary portion having at least one weak seal portion which is closed by separably bonding inside surfaces of the plastic films mutually facing at the boundary portion so that the one infusion solution and the another infusion solution or medicament in the respective chambers are mixed together when the weak seal portion is opened, wherein the weak seal portion is formed by applying a separable coating material, which provides a reduced bonding strength in a heat sealing process, on one or both inside surfaces of the plastic films mutually facing at the boundary portion and then effecting heat sealing process to the boundary portion.
- the separable coating material may contain at least one kind of silicone release agents.
- the boundary portion may have a seal portion hard to be opened other than the weak seal portion.
- the infusion solution bag of the present invention it is possible to form the weak seal portion in a relatively easy manner such that the separable coating material is applied on one or both inside surface of the plastic films forming the front and back wall of the bag respectively. Therefore, there is no need to provide a pinching member for pinching the infusion solution bag, a port forming member of a molded product or a resin film for weakening a sealing strength of the boundary portion between the chambers, and also no need to mount them on a predetermined position of the bag, thus forming the infusion solution bag with no trouble and labor.
- the weak seal portion is formed by applying the separable coating material on the inside surface of the plastic film, the weak seal portion can be easily made into an optional pattern in comparison with the conventional openable portion provided with the pinching member, the port forming member, the resin film for weakening the sealing strength or the like.
- the small chambers can be formed so as to have optional shapes at desired positions, thus performing the mixing of the inner contents of the respective small chambers in a correct mixing order.
- the separable coating material is applied in a form of a dot-pattern.
- the sealing strength of the weak seal portions can be finely controlled by changing an area-proportion of the dots, thus adequately adjust a separable performance of the weak seal portions.
- the stable sealing strength can be always achieved and all the products have uniform sealing strength.
- One chamber which is filled with the infusion solution to be flowed out into another chamber adjacent to the one chamber by opening the weak seal portion formed between both the chambers, may have a portion protruded towards the weak seal portion.
- the small chambers of the bag can be formed in an optional shape at a desired position, thus the chamber can be also formed in the protruded shape.
- an infusion solution bag which has front and back wall portions each formed of a flexible plastic film and which is provided with a plurality of chambers which are filled with one infusion solution and another infusion solution or medicament, independently, the chambers being sectioned by a boundary portion having at least one weak seal portion which is closed by separably bonding inside surfaces of the plastic films mutually facing at said boundary portion so that one infusion solution and the another infusion solution or medicament in the respective chambers are mixed together, the manufacturing method comprising the steps of:
- the separable coating material may preferably be applied in a form of dot-pattern to be changeable in area ratio thereof for adjusting separability of the weak seal portion.
- the separable coating material is applied so as to provide a dot-pattern on the inner surface of the plastic film through a printing process.
- the separable coating material may contain at least one kind of silicone release agents.
- the portions of the boundary portion other than the weak seal portion and the peripheral edge portion of the bag can be heat-sealed together with the weak seal portion, so that the infusion solution bag provided with small chambers can be effectively manufactured. Furthermore, since the separable coating material can be applied through the printing process to the weak seal portion at the inside surface of the plastic film, the area-proportion of dots in the printing process can be easily adjusted as well as easy formation of the weak seal portion with optional pattern.
- FIG. 1 is a front view of one embodiment of a bag for an infusion solution (infusion solution bag 1A) according to the present invention.
- the infusion solution bag 1A is one for artificial dialysis, which is prepared by overlapping two transparent flexible plastic films 2 (2a, 2b), and peripheral portions 3 thereof are heat sealed to thereby provide a bag having sealed four side peripheral portions, called hereinafter as four-side seal bag or merely seal bag.
- the infusion solution bag 1A has an inner space which is divided into two small chambers or sections 7a and 7b by a boundary portion 4 crossing a shell portion of the bag 1A.
- a dialysis solution is accommodated in one 7a of small chambers and an alkaline solution is accommodated in the other one 7b thereof so as to make neutral the dialysis solution, these solutions being independently sealed.
- the boundary portion 4 is sealed and closed by heat sealing the opposing plastic films 2a and 2b constituting front and back wall portions (front and back surface portions) of the infusion solution bag 1A.
- the boundary portion 4 has both side end portions, near the peripheral sides of the bag, at which both the front and back wall portions 2a and 2b are firmly bonded.
- the boundary portion 4 also has a central portion 5 shown by oblique lines which is weakly bonded so as to be separable as a weakly sealed portion 5, which may be called herein merely as weak seal portion 5.
- a central portion 5 shown by oblique lines which is weakly bonded so as to be separable as a weakly sealed portion 5, which may be called herein merely as weak seal portion 5.
- the boundary portion 4 of the infusion solution bag 1A shown in FIG. 1 has a separable portion as the weak seal portion 5 and also has a firmly sealed portion not separated, the boundary portion 4 may be formed entirely as the weak seal portion 5 as shown in FIG. 2.
- the separable weak seal portion 5 can be formed in a manner that a separable coating material such as silicone separable materials (release agents) is applied to either one of or both of inside surfaces of the plastic films 2a and 2b of the front and back wall portions of the bag 1A and then heat sealing process is performed to that portion to thereby form the weak seal portion 5.
- a separable coating material such as silicone separable materials (release agents)
- the weak seal portion 5 is constituted by an area formed by overlapping an area 6 of the plastic film to which the coating material is applied and the boundary portion 4 to which the heat sealing process is applied.
- the separable coating material applied area 6 is set so as to have a width slightly larger than that of the boundary portion 4 for the purpose of easily positioning the area 6 and the boundary portion 4. However, it will be easily understood that it is preferable to set the width of the coating material applied area 6 equal to that of the boundary portion 4 for preventing the applied coating material from directly contacting to the infusion solution in the sectioned chambers of the bag 1A.
- the separable coating material is applied to the weak seal portion 5 of the plastic film of the infusion solution bag 1A in a dot-pattern with a predetermined area-proportion of dots (dot percentage).
- the bonding strength i.e.
- the separable performance, of the bonding surface of the weak seal portion 5 can be controlled by adjusting the area-proportion of dots of the coating material in a manner such that when the infusion solution bag 1A is not separated, for example, in a time of reserving the bag as it is, the sealed condition can be suitably maintained, whereas when either one of small chambers 7a or 7b is pressed with a pressure such as that easily applied by a weight of a user from outside of the bag, the weak seal portion 5 is easily separated and the infusion solutions or the like accommodated in both the chambers 7a and 7b are mixed.
- the area-proportion of dots at the central portion of the weak seal portion 5 may be higher than that at both the end portions thereof.
- the area-proportion of dots at the central portion of the weak seal portion 5 is made to 50% and that of the end portion is made to 30%.
- the area-proportion of dots at both side edge portions of the weak seal portion 5 facing the small chambers of the bag may be made smaller than the other portion thereof and, in the example shown in FIG.
- the area-proportion of dots at both the side edge portions of the weak seal portion 5 facing the small chambers 7a and 7b of the bag is made to 30% and that at the central portion between both the side edge portions is made to 50%.
- a separable coating material is applied first to the entire portion of the weak seal portion 5 and, then, the separable coating material is additionally applied, in an overlapped manner, to a partial portion of the weak seal portion 5.
- the separable coating material is entirely applied to the weak seal portion 5 on the plastic film 2 with the area-proportion of dots of 50% and is further partially applied thereto in the overlapped manner with the area-proportion of dots of 30%.
- discharge members 8a and 8b made of plastic material are provided for the upper and lower end portions, as viewed in FIG.1, for example, of the infusion solution bag 1A.
- the discharge members 8a and 8b have tip end portions to which flanged portions 10 are formed so as to extend bilateral directions, and these flanged portions 10 and the inner surface of the peripheral portion of the plastic film 2a or 2b are heat-sealed.
- the discharge members 8a and 8b are formed with inner flow passages 9 communicating the inner spaces of the chambers with a space outside the infusion solution bag 1A, and the flow passages 9 are closed by means of rubber plugs.
- the weak seal portion 5 thereof is separated and opened so that the infusion solutions or the like in the respective small chambers of the bag 1A are mixed together, and the mixed solution can be discharged outward by, for example, piercing a needle of an injector attached to one end of an instillation tube to the rubber plug applied to the discharge member 8a (8b) of the infusion solution bag 1A.
- the infusion solution bag 1A of the structure mentioned above will be manufactured in the following manner.
- a flexible plastic film as a material for forming an infusion solution bag is cut, as shown in FIG. 6, to prepare plastic films 2a and 2b constituting front and back wall portions (front and back side surfaces) of the bag.
- plastic films 2a and 2b constituting front and back wall portions (front and back side surfaces) of the bag.
- plastic films 2a and 2b constituting front and back wall portions (front and back side surfaces) of the bag.
- PP polypropylene
- PVC plasticized polyvinyl chloride
- LLDPE flexible linear low density polyethylene
- EVA flexible ethylene vinyl acetate copolymer film or the like.
- a composite film formed by laminating a plurality of layers of different plastic materials may be used as a material for an infusion solution bag. It is desired for such film to have a thickness of about 200 to 500 ⁇ m.
- a heat seal layer may be additionally formed to an inside surface of the plastic film, particularly, at portions constituting the peripheral edge portion and the boundary portion of the infusion solution bag by
- a separable coating material is applied to the area, constituting the weak seal portion 5, shown with oblique lines in FIG. 7, of the inside surface of the plastic film 2a as the front wall portion of the bag.
- a positioning mark 12 is applied to an inconspicuous portion of the plastic film and the separable coating material is then applied to the predetermined portion with reference to this mark 12.
- a print coating method may be most preferred in various coating methods for the reason that the print coating method is most suitable for coating the material in optional pattern.
- the separable coating material it is required for the separable coating material to have a property for suppressing a bonding strength of the heat-sealed bonded surface and also have a heat-resisting property and a safeness for a human body.
- various hardenable type coating agents included in silicones, polyvinyl chloride compounds, epoxy compounds, polyesters, or the like materials there will be used various hardenable type coating agents included in silicones, polyvinyl chloride compounds, epoxy compounds, polyesters, or the like materials. Among these materials, the hardenable type silicone separable agents (release agents) will be most suitable in the viewpoint of safeness.
- the hardenable type silicone separable agent is used as a release agent which is coated to a release paper of a tack label or adhesion tape, it is necessary for the separable agent for the present invention to have safeness property for the human body.
- one desired coating material for the present invention will be a silicone release agent which can be hardened by the use of platinum catalyst. Standards or references of materials for medical use are different in respective countries, and in Japan, it is necessary for the separable coating material to pass test required for plastic containers for infusion solutions on the basis of the Japanese Pharmacopoeia.
- the easily separable coating material may be applied to an area 6 (enclosed with dotted lines in FIG. 7) which has a width slightly wider than that of an area (shown with one-dot-chain line in FIG. 7) constituting the boundary portion 4.
- an area 6 enclosed with dotted lines in FIG. 7 which has a width slightly wider than that of an area (shown with one-dot-chain line in FIG. 7) constituting the boundary portion 4.
- the easily separable coating material is applied to such wide area 6, the positional alignment between this area 6 and the area constituting the boundary portion 4 can be easily performed.
- the separable coating material may be applied to the inside surface of the plastic film 2b of the back wall portion forming the weak seal portion as well as the inside surface of the plastic film 2
- both the plastic films 2a and 2b are overlapped so that the inside surfaces thereof face each other, and then, the discharge members 8a and 8b are provided to the predetermined positions so that the flanged portions 10 of these discharge members 8a and 8b are interposed between the plastic films 2a and 2b.
- a single sheet of plastic film may be used as the plastic films 2a and 2b, and in this case, the single plastic film sheet is folded at the central portion thereof so as to form the front wall side plastic film 2a and the back wall side plastic film 2b.
- the areas constituting the peripheral edge portions 3 and the boundary portion 4 of the infusion solution bag 1A are heat-sealed, and at this process, as to the area constituting the boundary portion 4, all the portions including the weak seal portion 5 and the other portions are heat-sealed. Further, at this time, since the filling of the infusion solution has not been completed, it will be desired that the areas constituting the peripheral edge portions 3 and the boundary portion 4 remain unsealed partially, i.e. one portion to each area, without heating so as to provide infusion solution filling ports 11a and 11b.
- the infusion solution is fed into the bag 1A through the discharge members 8a and 8b, it is not necessary for the unsealed portion to remain because the infusion filling ports can be automatically formed by mounting the discharge members 8a and 8b to the infusion solution bag 1A.
- a bar-seal method, a high-frequency seal method, an ultrasonic-seal method or other known heat seal methods will be utilized.
- the infusion solutions or other substances are filled up in the respective small chambers.
- a medicament such as powder medicament or a little amount of medicament solution other than the infusion solution.
- the filling ports 11a and 11b are heat-sealed and the flow passages 9 of the discharge members 8a and 8b are closed by means of rubber plug. A retort sterilization or other treatment will be performed as occasion demands.
- the infusion solution bag 1A such as shown in FIG. 1 can be manufactured by performing the above-mentioned processes.
- the bonding strength of the plastic film 2a forming the front wall portion and the plastic film 2b forming the back wall portion at the weak seal portion 5 can be adjusted by selecting the separable coating materials or changing the heat-sealing temperature or heat-seal pressure, and preferably, it is desired to apply the easily separable coating material in dot-shape pattern while changing the area-proportion of the dots, thus performing the fine adjustment. Furthermore, according to the adjustment by using the area-proportion of dots, the stable sealing strength can be always achieved and all the products have uniform sealing strength.
- the easily separable coating material can be easily printed in the dot-pattern by the printing method and, in this method, the area-proportion of dots can be optionally changed.
- two films of polypropylenes each having a thickness of 300 ⁇ m were overlapped and then heat-sealed at a heating temperature of 210 °C with a sealing pressure of 2 kg/cm 2 for 3 seconds, thus forming a test piece having a width of 15 mm.
- the sealing strength was about 5.1 kg/15mm (width).
- a hardenable-type separable agent of silicones was applied to the inside surface of one of the same polypropylene films in the dot-pattern having an area-proportion of dots of 50% as shown in FIG. 10 through the printing method and then heat-sealed with the same conditions mentioned above.
- the sealing strength was adjusted to about 1.4 kg/15mm (width). Furthermore, in the same manner, when the hardenable-type separable agent of silicones was applied to the inside surface of the other one of the polypropylene films in the dot-pattern having an area-proportion of dots of 30% as shown in FIG. 11 through the printing method and then heat-sealed with the same conditions mentioned above. In this case, the sealing strength was adjusted to about 2.7 kg/15mm (width).
- the suitable sealing strength of the weak seal portion to be determined differs in accordance with the differences of the amounts of the inner contents of the infusion solution bag, the kind of users such as man or woman, or other conditions.
- the sealing strength can be finely and optionally adjusted by changing or adjusting the area-proportion of dots.
- the infusion solution bag will be formed to have a general structure provided with a linear weak seal portion such as shown in FIG. 1.
- the infusion solutions or the other medicament in the chambers have a combination having a fear of being denatured or discolored if the mixing order thereof is not correctly carried out and, hence, in a case where it is necessary to carry out the mixing thereof with the predetermined order, it is required for the infusion solution bag to be formed with the small chambers having shapes or positions suitable for carrying out the correct mixing order of the inner contents.
- the boundary portion including such weak seal portion can be formed so as to have an optional pattern, and accordingly, small chambers each having an optional shape can be easily formed to an optional position. Furthermore, according to the printing method such as gravure printing method, the separable coating material can be particularly easily applied in the desired pattern shape.
- FIG. 12 shows another example of an infusion solution bag 1B of the present invention.
- the boundary portion 4 has a central portion protruded towards a small chamber side 7d so as to provide a V-shape in a manner such that the inner space of a small chamber 7c is narrowed towards the weak seal portion 5 formed between the small chambers 7c and 7d.
- the inner pressure applied to the small chamber 7c is concentrated to the narrowed central portion thereof, i.e. toward the weak seal portion 5, and therefore, when the weak seal portion 5 is separated and opened, the infusion solution in the small chamber 7c flows into the other small chamber 7d.
- the inner pressure is hardly concentrated to the central portion thereof, i.e. the weak seal portion 5, so that the weak seal portion 5 will be hard to be separated and opened, and hence, the flow of the infusion solution from the small chamber 7d to the small chamber 7c will be hardly caused.
- FIG. 13 shows a further example of an infusion solution bag 1C of the present invention provided with three small chambers 7e, 7f and 7g into which different three kinds of infusion solutions are accommodated.
- the boundary portions 4 between the small chamber 7e and the small chambers 7f and 7g have central portions narrowed, i.e. protruded, towards the small chamber side so as to provide a V-shape in the manner similar to that mentioned above.
- the small chamber 7e is first pressed so as to mix the infusion solution therein with the infusion solution contained in the small chamber 7f by flowing the infusion solution in the small chamber 7e into the small chamber 7f through the opened weak seal portion 5, and thereafter, the small chamber 7e is again pressed so as to mix the infusion solution therein with the infusion solution contained in the small chamber 7g by flowing the first mixed infusion solution in the small chamber 7e into the small chamber 7g to thereby mix all the infusion solutions in the chambers 7e, 7f and 7g.
- the direct mixing between the infusion solutions in the small chambers 7f and 7g can be prevented, and it is not necessary to form any weak seal portion between the small chambers 7f and 7g because the infusion solutions in these chambers are mixed through the small chamber 7e. Further, if the infusion solution bag 1C is formed so that the sealing strengths between the weak seal portions of the small chambers 7f and 7g is different, the above mentioned mixing will be more accurately performed.
- the infusion solution bag provided with a plurality of small chambers into which the infusion solutions and/or medicaments are accommodated respectively and which have the weak seal portions closed with suitable sealing strength to be easily separable can be effectively manufactured. Furthermore, the sealing strength of the weak seal portions can be optionally adjusted finely in accordance with the requirements to be used, and the thus manufactured product infusion solution bags provide uniform sealing strength.
- the small chambers can be formed so as to have optional shapes at desired positions, the mixing of the inner contents of the respective small chambers can be correctly performed.
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Package Specialized In Special Use (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP33904897 | 1997-12-09 | ||
JP33904897A JPH11169432A (ja) | 1997-12-09 | 1997-12-09 | 輸液バッグ及びその製造方法 |
Publications (3)
Publication Number | Publication Date |
---|---|
EP0920849A2 true EP0920849A2 (fr) | 1999-06-09 |
EP0920849A3 EP0920849A3 (fr) | 2000-03-15 |
EP0920849B1 EP0920849B1 (fr) | 2003-07-23 |
Family
ID=18323772
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19980304166 Expired - Lifetime EP0920849B1 (fr) | 1997-12-09 | 1998-05-27 | Sac pour solutions d'infusion et procédé de fabrication |
Country Status (3)
Country | Link |
---|---|
US (2) | US6186998B1 (fr) |
EP (1) | EP0920849B1 (fr) |
JP (1) | JPH11169432A (fr) |
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Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1288141A3 (fr) * | 2001-08-06 | 2003-11-26 | Hosokawa Yoko Co., Ltd | Matériau d'emballage et sachet d'emballage fabriqué à partir de ce matériau |
US7040483B2 (en) | 2001-08-06 | 2006-05-09 | Hosokawa Yoko Co., Ltd. | Packaging bag with weak sealed duct |
EP1288141A2 (fr) * | 2001-08-06 | 2003-03-05 | Hosokawa Yoko Co., Ltd | Matériau d'emballage et sachet d'emballage fabriqué à partir de ce matériau |
US7776414B2 (en) | 2002-03-28 | 2010-08-17 | Hosokawa Yoko Co., Ltd. | Infusion container with multiple chambers |
WO2003082549A1 (fr) * | 2002-03-28 | 2003-10-09 | Showa Denko Plastic Products Co., Ltd. | Recipient d'infusion a plusieurs chambres et son procede de production |
FR2887487A1 (fr) * | 2005-06-27 | 2006-12-29 | Solvay Ind Foils Man And Res | Procede de soudure de matieres plastiques |
WO2007000273A1 (fr) * | 2005-06-27 | 2007-01-04 | Renolit Ag | Procédé permettant de souder du plastique |
FR2897342A1 (fr) * | 2006-02-15 | 2007-08-17 | Com Dose Sarl | Procede de fabrication d'un contenant du type comportant deux ou plusieurs compartiments |
WO2007093713A3 (fr) * | 2006-02-15 | 2007-10-11 | Com Dose | Procede de fabrication d ' un contenant comportant deux ou plusieurs compartiments ainsi que le contenat obtenu |
WO2007093713A2 (fr) * | 2006-02-15 | 2007-08-23 | Com Dose | Procede de fabrication d ' un contenant comportant deux ou plusieurs compartiments ainsi que le contenat obtenu |
NL1033968C2 (nl) * | 2007-06-11 | 2008-12-12 | Sara Lee De Nv | Houder. |
WO2008153383A1 (fr) * | 2007-06-11 | 2008-12-18 | Sara Lee/De N.V. | Support |
US9027465B2 (en) | 2007-06-11 | 2015-05-12 | Koninklijke Douwe Egberts B.V. | Holder |
WO2020225352A3 (fr) * | 2019-05-08 | 2020-12-30 | Schlack Stefan | Sac pour la production d'aliments pour bébé, dispositif de régulation de température des aliments pour bébé et procédé de production d'aliments pour bébé |
CN114449988A (zh) * | 2019-05-08 | 2022-05-06 | 斯米伊克斯有限责任公司 | 用于婴儿食品制备的袋子、用于婴儿食品温度调节的设备和婴儿食品制备的方法 |
Also Published As
Publication number | Publication date |
---|---|
EP0920849A3 (fr) | 2000-03-15 |
EP0920849B1 (fr) | 2003-07-23 |
US20010000042A1 (en) | 2001-03-15 |
JPH11169432A (ja) | 1999-06-29 |
US6186998B1 (en) | 2001-02-13 |
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